A study of VTX958 adipate modified release tablet formulations in healthy subjects
| ISRCTN | ISRCTN97798065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97798065 |
| Integrated Research Application System (IRAS) | 1006953 |
| Quotient Code | QSC205947 |
| Sponsor code | VTX958-105 |
| Sponsor | Ventyx Biosciences, Inc. |
| Funder | Ventyx Biosciences, Inc. |
- Submission date
- 17/02/2023
- Registration date
- 23/02/2023
- Last edited
- 13/05/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The Sponsor is developing a new formulation (recipe) of VTX958 (the test medicine) to treat inflammatory and autoimmune conditions. This healthy volunteer study will assess the performance of new formulations (recipes) of the test medicine when given as single doses and multiple doses. This study will also investigate how these recipes will be affected when taken with and without food. The extent to which the test medicine is taken up by the body will be measured and the safety and tolerability of the test medicine will be monitored throughout.
Who can participate?
Healthy male volunteers aged between 18 and 60 years.
What does the study involve?
This study will take place at one non-NHS site. In Part 1, volunteers will receive at least 3 and up to 4 single doses of the test medicine on 3 or 4 separate occasions, once daily dosing for 4 days on up to 2 possible occasions, and twice daily dosing for 4 days on 1 occasion. Volunteers will receive a follow-up phone call 5 to 7 days post final dose. Volunteers will be discharged from the study once they have completed the follow-up phone call in their final study period. Volunteers are expected to be involved in this study for approximately 15 weeks from screening to the follow-up call.
In Part 2, volunteers will receive at least 1 and up to 3 single doses of the test medicine on up to 3 separate occasions, once daily dosing for 4 days on up to 2 possible occasions, and divided doses over a 9 h period (potentially a 6 to 12 h period) on 1 possible occasion. Volunteers will receive a follow-up phone call 5 to 7 days post final dose. Volunteers will be discharged from the study once they have completed the follow-up phone call in their final study period. Volunteers are expected to be involved in this study for approximately 12 weeks from screening to the follow-up call.
What are the possible risks and benefits of participating?
1. As this is a Phase I study, the most relevant population is healthy volunteers. It is considered that the risk/benefit evaluation in this study supports the use of healthy volunteers.
2. There is always a risk that the stipend in healthy volunteer studies could represent coercion. The time spent in the clinic, travel, inconvenience and other expenses factor in calculating the stipend. Perception of risk is not considered in this calculation.
3. When investigating new medicines, there is always a risk of unexpected side effects and occasionally allergic reactions. Volunteers will be closely monitored during the study.
4. Volunteers may experience side effects from the test medicine in this study. Full information on possible side effects is provided to volunteers in the Participant Information Sheet and Informed Consent Form.
5. There will be an extended period of fasting for the volunteers taking part in this study. To ensure an adequate fluid intake, the volunteers will be allowed water up to 1 hour before dosing and will be provided with water 1 hour after dosing. Volunteers will then be allowed to drink water freely from this time. Decaffeinated fluids will be allowed freely from lunchtime on the day of dosing and will be monitored for signs of dehydration and fatigue.
6. Blood samples will be collected during the study. Collection of these samples can cause soreness and bruising of the arms, but these problems usually clear up within a few days to a few weeks.
7. ECG stickers on volunteers' chests and limbs may cause some local irritation and may be uncomfortable to remove, but volunteers will be closely monitored to ensure any local irritation does not persist.
Where is the study run from?
Ventyx Biosciences, Inc (USA)
When is the study starting and how long is it expected to run for?
April 2023 until November 2023
Who is funding the study?
Ventyx Biosciences, Inc (USA)
Who is the main contact?
Ventyx Clinical Trial Contact, ClinicalTrials@ventyxbio.com
Contact information
Principal investigator
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 3031000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public
Ventyx Biosciences Inc., a wholly owned subsidiary of Eli Lilly and Company
12790 El Camino Real, Suite 200
San Diego
CA 92130
United States of America
| Phone | +1 888 411 5176 |
|---|---|
| ClinicalTrials@ventyxbio.com |
Scientific
Ventyx Biosciences Inc., a wholly owned subsidiary of Eli Lilly and Company
12790 El Camino Real, Suite 200
San Diego
CA 92130
United States of America
| Phone | +1 888 411 5176 |
|---|---|
| ClinicalTrials@ventyxbio.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Dose comparison |
| Assignment | Parallel |
| Purpose | Phase I pharmacokinetics study in healthy volunteers |
| Scientific title | A single and multiple dose study to evaluate the pharmacokinetics of VTX958 adipate modified release tablet formulations in healthy subjects |
| Study objectives | The trial will meet the following primary and secondary objectives: Primary: • To characterise the pharmacokinetics (PK) of VTX958 following single dose administration of VTX958 Adipate Modified Release (MR) Tablet Prototype formulations in the fasted and fed state. • To characterise the PK of VTX958 following single (Day 1) and multiple dose administration (Day 3) of VTX958 Adipate MR Tablet Prototype formulations in the fasted or fed state and multiple dose administration of VTX958 Adipate MR Tablet Prototype formulations in the fasted or fed state (Day 4). • To characterise the PK of VTX958 following single (Day 1) and multiple dose administration (Day 3) of VTX958 Film Coated Tablet (Immediate Release [IR] reference) formulation in the fasted or fed state and multiple dose administration of VTX958 Film Coated Tablet (IR reference) formulation in the fasted or fed state (Day 4). • Assess the relative bioavailability of the VTX-958 Adipate MR Tablet Prototype formulations compared to the VTX958 Film Coated Tablet (IR reference) formulation in the fasted or fed state after single (Day 1) and multiple dose administration (Day 3). Secondary: • To determine the relative bioavailability of the VTX958 Adipate MR Tablet Prototype formulations in the fed or fasted state after multiple dose administration relative to the fed or fasted state. • To assess safety and tolerability for single and multiple doses of VTX958.Adipate when administered as MR Tablet Prototype formulations. |
| Ethics approval(s) |
1. Approved 03/04/2023, Wales REC 2 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2071048222, +44 (0)2920230457, +44 (0)7920 565664; Wales.REC2@wales.nhs.uk), ref: 23/WA/0014 2. Approved 03/04/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 57619/0001/001-0001 |
| Health condition(s) or problem(s) studied | Immune-mediated and inflammatory disorders with initial indications in psoriasis, psoriatic arthritis, and Crohn’s disease. |
| Intervention | This is a randomised controlled trial in which healthy participants are assigned to one of two or more groups and remain in their assigned group for the duration of the study. This healthy volunteer study will assess the performance of new formulations (recipes) of the test medicine when given as single doses and multiple doses. The extent to which the test medicine is taken up by the body will be measured and the safety and tolerability of the test medicine will be monitored throughout. This study will take place at one non-NHS site, and is planned to enrol 20 male volunteers in Part 1 and 18 male volunteers in Part 2, aged between 18 and 60 years. In Part 1, volunteers will receive at least 3 and up to 4 single oral doses of the test medicine (VTX958 Adipate MR Tablet Prototypes or VTX958 Film Coated Tablet) on 3 or 4 separate occasions, once daily oral dosing for 4 days on up to 2 possible occasions, and twice daily oral dosing for 4 days on 1 occasion. Volunteers are expected to be involved in this study for approximately 15 weeks from screening to the follow-up call. In Part 2, volunteers will receive at least 1 and up to 3 single oral doses of the test medicine (VTX958 Adipate MR Tablet Prototypes or VTX958 Film Coated Tablet) on up to 3 separate occasions, once daily oral dosing for 4 days on up to 2 possible occasions, and divided oral doses over a 9 h period (potentially a 6 to 12 h period) on 1 possible occasion. Volunteers are expected to be involved in this study for approximately 12 weeks from screening to the follow-up call. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | VTX958 Adipate MR Tablet Prototypes 1-X 150 mg, VTX958 Adipate MR Tablet Prototypes M1-MX 150 mg – 300 mg, VTX958 Film Coated Tablet 125 mg (IR Reference), VTX958 Film Coated Tablet 50 mg (IR Tablet) |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 17/11/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Male |
| Target sample size at registration | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | Current key inclusion criteria as of 07/05/2026: 1. Must provide written informed consent 2. Must be willing and able to communicate and participate in the whole study 3. Aged 18 to 60 years inclusive at the time of signing informed consent 4. Must agree to adhere to the contraception requirements 5. Healthy males 6. Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2 as measured at screening 7. Weight ≥50.0 kg at screening Previous inclusion criteria: Healthy human volunteer |
| Key exclusion criteria | 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 3. Presence of or history of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator 4. History of fits or seizures, including childhood febrile convulsions 5. Subjects with a history of cholecystectomy or gallstones 6. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 7. Evidence of current or history of SARS-CoV-2 infection within 2 weeks of first IMP administration 8. Clinically significant abnormal clinical chemistry, haematology or urinalysis at screening or first admission as judged by the investigator. Subjects with Gilbert’s syndrome are not allowed. 9. Haemoglobin level below the lower limit of the laboratory reference range at screening or first admission 10. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results at screening 11. History of treated, latent or active tuberculosis, including positive QuantiFERON assessed at screening 12. Active or presence of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia), serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicaemia) within 3 months prior to screening 13. Presence or history of fever (body temperature >37.6°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dose 14. Subjects who have received any IMP in a clinical research study within the 90 days prior to Period 1, Day 1, or less than 5 elimination half-lives prior to Period 1, Day 1, whichever is longer 15. Subjects who have previously been administered IMP in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2. 16. Donation of blood or plasma within the previous 3 months prior to screening or loss of greater than 400 mL of blood by any other means 17. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 2 g of paracetamol per day) in the 14 days before first IMP administration. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic (PD) activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study.↲ 18. Subjects who have had a COVID-19 vaccine or any other vaccine 14 days before first IMP administration 19. Subjects who have any plans to travel abroad during the study 20. History of any drug or alcohol abuse in the past 2 years prior to screening 21. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type) 22. A confirmed positive alcohol breath test at screening or first admission 23. Current smokers and those who have smoked within the last 6 months prior to screening 24. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or first admission 25. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months prior to screening 26. Confirmed positive drugs of abuse test result 27. Male subjects with pregnant or lactating partners 28. Failure to satisfy the investigator of fitness to participate for any other reason |
| Date of first enrolment | 05/04/2023 |
| Date of final enrolment | 15/09/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
07/05/2026: The following changes were made:
1. Public title changed from "Phase I Trial, Quotient Code: QSC205947".
2. Scientific title changed from "Phase I Trial, Quotient Code: QSC205947 [The full scientific title will be published within 30 months after the end of the trial]".
3. Study objectives, interventions, drug/device/biological/vaccine name(s), primary and secondary outcomes, key inclusion and exclusion criteria, allocation, masking, control, assignment, purpose, final enrolment number, and plain English summary of protocol added.
4. The health condition was changed from healthy volunteers to immune-mediated and inflammatory disorders with initial indications in psoriasis, psoriatic arthritis, and Crohn’s disease.
5. Date of first enrolment was changed from 04/04/2023 to 05/04/2023.
6. Date of final enrolment was changed from 17/11/2023 to 15/09/2023.
7. Public and scientific contacts were updated.
05/12/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 28/07/2023 to 17/11/2023.
2. The overall study end date was changed from 28/07/2023 to 17/11/2023.
3. The intention to publish date was changed from 28/01/2026 to 17/05/2026.
05/04/2023: The HRA has confirmed that it has approved deferral.
05/04/2023: The ethics approval was added.
23/02/2023: Trial's existence confirmed by MHRA.
